It is commonplace in a variety of clinical situations, including reduced levels of consciousness, sequelae to trauma or illness, or advanced age, for patients to lose control of the discharge of urine. It is generally preferrable to avoid transurethral catheterization of the urinary bladder as infection, unnecessary discomfort, or internal injury can result. In the male patient, external or condom catheters are useful in this regard.
The external or condom catheter generally comprises an elongated sheath of one-piece construction having a thickened tubular forward portion defining a central fluid passage and connectable to a suitable drainage tube, an intermediately positioned conical body portion having a lesser thickness and providing a forward discharge opening, and a respectively thin-walled rearward portion of a diameter and length sufficient to circumscribe a substantial length of the penis. It is usual for the rearward portion of the catheter to be prepared in an initial rolled up attitude and to be applied to the penis by placing the free end thereof within the conical body portion and then manually unrolling the rearward portion of the catheter over the shaft of the penis.
To secure the catheter in place to the penis after application, and to prevent urine leakage around and beyond its rearward portion, one method employed comprises the application of a spongy adhesive-coated liner pad circumferentially around the shaft of the penis and then an unrolling of a rearward portion of a catheter thereover and beyond the linear pad, as in the Hauser patent.
Another method used to effect an attached relation to the penis and to provide a sealing means is taught by a product similar to the Hickock patent, manufactured by the Mentor Corporation under the name Freedom Cath, and also by a product manufactured by Hollister Incorporated known as The Hollister.TM. Self-Adhesive Uninary External Catheter. In both the Mentor device and the related Hollister device, the attached and sealing means comprises an adhesive coating applied to the inner surface of the rearward portion of the catheter. When unrolled over the shaft of the penis, the adhesiveness of the rearward portion serves to adhere, in an occlusive manner, directly to the skin of the penis. Found additionally in the Hollister device is an annular and forwardly extending inner flap, existing in the vicinity of the origin of the rearward portion of the device and bonded thereto, which serves exclusively as a seal with the glans of the penis to prevent the backflow of urine.
To function as intended, it is desirable to maintain the free end of the penis in near approximation to the forward discharge opening and within the conical body portion of the external catheter. When properly maintained in such a position, a twisting, collapsing, or kinking of the cathether to a degree which restricts the outflow of urine is prevented. Heretofore, external or condom catheters have been found unsatisfactory in this respect. Often encountered when applying the catheter is a problem which occurs when unrolling the catheter over the penis. Namely, the act of unrolling the rearward portion of the catheter tends to push the free end of the penis away from the forward discharge opening and from a proper position within the conical body portion, contributing to an ill-fitting of the device. Similarly, the relative looseness of the penile skin tends to be pushed ahead of the roll as it is unrolled during application, displacing the skin rearwardly away from a normally relaxed position. After application, i.e. unrolling the catheter, the penile skin will return to a relaxed state and cause the free end of the penis to displace and withdraw from its desired position within the catheter. Additionally, an ill-fitting of the catheter can result from an accidental pulling or stretching of the catheter, effecting a like change in position of the free end of the penis with respect to its forward discharge opening and conical body portion.